ABSTRACT

Herbal drug technology includes all the steps that are involved in converting botanical materials into medicines, where standardization and quality control with proper integration of modern scientific techniques and traditional knowledge will remain important. The German market exists for monographs of standardized marketing authorization and temporary marking authorization for old herbal drugs until they are evaluated for safety and efficacy. National regulation and registration of herbal medicines vary from country to country. Where herbal medicines are regulated, they may be categorized as either prescription or nonprescription medicines. Challenges in monitoring the safety of herbal medicine and the need for good communications for ensuring successful safety monitoring are also stressed. In 1997, World Health Organization developed a draft guideline for methodology on research and evaluation of traditional medicine (TM). TM are indigenous medicines existent in the region either recognized or ethnic as in Chinese medicine, Indian Ayurveda, Arabic Unani medicine, African, and Latin American practices.